rvnc-20211015000147929010/15/2021FALSE00014792902021-10-152021-10-15
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
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| CURRENT REPORT |
| Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 |
Date of Report (Date of earliest event reported): October 15, 2021
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| Revance Therapeutics, Inc. |
| (Exact name of registrant as specified in its charter) | |
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| Delaware | 001-36297 | 77-0551645 |
| (State or other jurisdiction of incorporation) | (Commission File No.) | (I.R.S. Employer Identification No.) |
1222 Demonbreun Street, Suite 2000, Nashville, Tennessee, 37203
(Address of principal executive offices and zip code)
(615) 724-7755
(Registrant’s telephone number, including area code)
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| Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (see General Instruction A.2. below): |
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| ☐ | Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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| ☐ | Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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| ☐ | Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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| ☐ | Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c)) |
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| Securities registered pursuant to Section 12(b) of the Act: |
| Title of each class | Trading Symbol(s) | Name of each exchange on which registered |
| Common Stock, $0.001 par value | “RVNC” | Nasdaq Global Market |
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).
Emerging growth company ☐
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ¨
ITEM 8.01 OTHER EVENTS
On October 15, 2021, Revance Therapeutics, Inc. (the “Company”) announced that the United States (U.S.) Food and Drug Administration (the “FDA”) has issued a Complete Response Letter (“CRL”) regarding the Company’s Biologics License Application (the “BLA”) for DaxibotulinumtoxinA for Injection, for the treatment of moderate to severe glabellar (frown) lines.
In a communication received by the Company on October 15, 2021, the FDA indicated it is unable to approve the BLA in its present form and indicated that there are deficiencies related to the FDA’s onsite inspection at the Company’s manufacturing facility. The Company plans to request a Type A meeting with the FDA as soon as possible to address the deficiencies raised.
SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
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| Date: | October 15, 2021 | Revance Therapeutics, Inc. |
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| | By: | /s/ Tobin C. Schilke |
| | | Tobin C. Schilke |
| | | Chief Financial Officer |